Opinion Medicine became poison – and our healthcare and regulatory systems failed

Early lab reports, surprisingly, found no toxins or banned substances in the cough syrups. The Union Ministry of Health and Family Welfare reported that laboratory analyses of samples collected from Chhindwara had neither detected diethylene glycol (DEG) nor ethylene glycol (EG). The MP State Food and Drug Administration (SFDA) also tested three samples and confirmed the absence of DEG or EG.

Industrial solvents such as DEG and EG are infamous for triggering acute kidney injury. Things, however, took a sharp turn when a report emerged from Tamil Nadu’s drug control department, which suggested that a batch of Coldrif cough syrup was not of standard quality and revealed 48.6 percent DEG contamination in the cough syrup.

The report revealed how a simple cough syrup turned poisonous and damaged the kidneys of innocent children and that the Tamil Nadu-based Sresan Pharmaceuticals had violated 364 manufacturing norms. Out of these, 39 norms were of a “critical” nature and 325 were the “major” ones. It exposed serious lapses such as unqualified staff, substandard water and equipment, absence of pest control, missing production monitoring systems, and a complete lack of quality assurance or data collection mechanisms. Even after all this, Tamil Nadu’s Health Minister dared to claim that the state acted swiftly and successfully prevented a larger crisis by responding promptly. If he really had done his duty, the unfit or contaminated syrups would never have ended in the market itself.

The Comptroller and Auditor General (CAG) in August 2024, in its performance audit report sent to Tamil Nadu, flagged some serious shortfalls in the testing of the pharmaceutical samples by Tamil Nadu’s Drug Control Body. It revealed that testing labs were being operated with outdated infrastructure, a shortage in staffing and delays in investigating the collected samples. Only a small fraction of the drug batches were being tested, well below the required level, leaving a majority of the medicines unmonitored.

These lapses have public health implications not just for Tamil Nadu but for the rest of the country as well, as drugs are distributed in different parts of the country. Situations like these raise serious doubts about the purpose of institutions like the CAG if the shortcomings and problems they highlight are never acted upon. There is little meaning in maintaining such bodies if their findings are not used to bring about corrective action.

All of this, however, only deepened the crisis, as the public health machinery misled rather than delivering accurate lab reports on time. How could the lab reports reveal completely opposite findings? Is it really that difficult to have a mechanism in place, capable and competent enough to actually perform the job they are meant to perform?

In an apparent attempt to project vigilance and decisive action, the government arrested a pediatrician from Parasia Civil Hospital after his name appeared on prescriptions linked to the case. He was charged under the Bharatiya Nyaya Sanhita and the Drugs and Cosmetics Act, and was promptly suspended from his duty. What exactly is the doctor truly guilty of? Trusting an approved drug? A physician operates within a system built on the presumption that the medicines cleared for public use are both safe and regulated. If the state’s own licencing and regulatory mechanisms fail to ensure that, the burden of systemic negligence cannot be displaced onto an individual practitioner. The tragedy, therefore, cannot lie in a single act of medical judgment but in the state’s dereliction of its regulatory duty.

Earlier reports had also highlighted that in Rajasthan, Kaysons Pharma, a company supplying dextromethorphan hydrobromide syrup under the Chief Minister’s Free Medicine Scheme, had faced similar scrutiny. A batch of its syrup reportedly failed quality testing six months ago and the product was initially banned for one year on February 21, 2025. However, it was later reinstated quietly, a move that raised serious concerns about transparency, accountability, and the integrity of the regulatory process.

The official response from the Rajasthan government was even more troubling. The State’s Health Minister, instead of taking responsibility for the tragedy, stated that the children were given cough syrup at home without medical advice. The Health Minister, in his statement, added that no child has died from the consumption of cough syrup. “One had meningitis (brain fever), and another had a respiratory infection. The medicine had been tested and was found to be appropriate”, he added (India Today). The minister tried to shift the responsibility from the healthcare system to the very grieving families. Such rhetoric, which is insensitive and evasive, reflects a deeper crisis of accountability in public health governance. It reveals that those in power always rush to protect themselves and happily forget their responsibility to protect their citizens.

The poor are not seen as rights-bearing citizens entitled to safe healthcare, but as reckless dependents whose suffering can be rationalised — a mindset which is deeply rooted within our institutions (or among those in power at least) where, instead of saying “the system failed these families,” the narrative becomes “they were careless,” “they didn’t follow instructions,” or “they should have known better.” It is a retreat of the state from its ethical obligations under the guise of administrative convenience.

The Supreme Court recently dismissed a Public Interest Litigation that sought a transfer of the FIRs relating to the cough syrup deaths to the Central Bureau of Investigation (CBI). It had sought a comprehensive inquiry into the manufacture, regulation, testing and distribution of contaminated cough syrups containing Diethylene Glycol, a toxic chemical used in industrial solvents, and suggestions for the safe manufacture of these medicines. Given that deaths have now been reported across multiple states, this cannot remain a state-specific inquiry. It needs a coordinated, multi-state probe under the supervision of central agencies such as the CBI and the Union Health Ministry. The tragedy may be far wider than what has actually been reported.

The writer is Advocate on Record, Supreme Court of India and Former Member, NHRC